Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions

Volunteers who met the following criteria were included in the study

• Were in the age range of 18-45 years.
• Were neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases
• Had voluntarily given written informed consent to participate in this study.
• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

• History of hypersensitivity to fenofibrate or any other related drug.
• Subjects with history of hepatic or severe renal dysfunction, including primary biliary cirrhosis.
• Subjects with history of unexplained persistent liver function abnormality.
• Subject had history of myalgia, muscle tenderness or weakness or myopathy.
• History of abdominal pain in one week preceding the study.
• History of recurrent headache and/or back pain.
• History of constipation and/or nausea in one week preceding the study.
• History and/or any finding of gall bladder disease.
• History of pancreatitis.
• History of drug-induced rash and/or pruritis. - Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Subject had laboratory test parameter(s), which is/are outside acceptable limits and is judged clinically significant.
• Subject had history of serious medical illnesses including but not limited to gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes, glaucoma, any serious, potentially life-threatening illness.
• Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that might impair the ability to provide, written informed consent.
• Subject was a regular smoker, who smoked more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
• Subject had history of drug dependence or excessive alcohol intake on a habitual basis or has difficulty in abstaining for the duration of each study period or has consumed alcohol 48 hours prior to admission.
• Subject had used an enzyme modifying drugs within 30 days prior to admission of this study.
• Subject had participated in a clinical trial within 12 weeks preceding admission of this study (except for subjects who dropout / are withdrawn from the previous study prior to period 1 dosing)
• Subject had donated and/or lost more than 350 mL of blood in the past 3 months, including blood loss in this study.
• Consumption of alcohol for 48 hours prior to admission.
• Subject had problem(s) in complying with the study protocol.